头孢拉定胶囊微生物限度检查方法的验证

Verification of Microbial Limit Test Method for Cephradine Capsules

目的:建立头孢拉定胶囊微生物限度检查方法并进行方法学验证。方法:头孢拉定胶囊总需氧菌总数计数方法采用平皿法和稀释法,霉菌和酵母菌总数计数方法采用平皿法,控制菌(大肠埃希菌)检查采用薄膜过滤法。按照《中华人民共和国药典》(2015年版)相关规定,对3批头孢拉定胶囊进行微生物限度检查的方法学验证。结果:(1)平皿法,金黄色葡萄球菌、铜绿假单胞菌和枯草芽孢杆菌的回收率均<0.5,未达到要求;稀释法,金黄色葡萄球菌、铜绿假单胞菌和枯草芽孢杆菌的回收率均>0.7,达到要求。(2)平皿法,白色念珠菌、黑曲霉菌的回收率≥0.7以上,符合规定。(3)大肠埃希菌检查具有专属性。结论:该微生物限度检查方法可行有效,可用于头孢拉定胶囊的微生物限度检查。

OBJECTIVE： To establish the microbial limit test method for cephradine capsules and to conduct the methodological verification. METHODS： The total number of total aerobic bacteria in cephradine capsules were counted by using plate method and dilution method; the total number of moulds and yeasts were counted by using plate method; and the membrane filtration method was used to detect control bacteria（ Escherichia coli）. According to the relevant regulations of the Chinese Pharmacopoeia（ 2015 Edition）,3 batches of Cefradine capsules were determined by microbial limit test method. RESULTS：（ Ⅰ） Plate method,the recoveries of staphylococcus aureus,pseudomonas aeruginosa and bacillus subtilis were all 〈0. 5,and did not meet the requirements; dilution method,the recoveries of staphylococcus aureus,pseudomonas aeruginosa and bacillus subtilis were all 〉0. 7,and met the requirements.（ Ⅱ）Plate method,the recoveries of candida albicans,aspergillus niger were all≥0. 7,and in line with the requirements;（ Ⅲ） The determination of Escherichia coli had specificity. CONCLUSIONS： The microbiological limit test method is feasible and effective,and can be used for the microbial limit test of Cephradine capsules.